Renal Pelvis and Ureter Urothelial CarcinomaNCT07630155
Office-Based Ureteroscopy Utilizing a Single Use Digital, Flexible Ureteroscope for Upper Tract Urothelial Carcinoma
A study testing Analgesic Agent, Electronic Health Record Review and Lidocaine Topical in people with Renal Pelvis and Ureter Urothelial Carcinoma, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial summary
This clinical trial tests how well office based ureteroscopy utilizing a single use digital, flexible ureteroscope works for the assessment of upper tract urothelial carcinoma. Ureteroscopy is a procedure in which a thin camera called a ureteroscope is used to assess patients with a known or suspected diagnosis of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Pelvis and Ureter Urothelial Carcinoma
- What is being tested?
- Analgesic Agent, Electronic Health Record Review and Lidocaine Topical
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged ≥ 18 year. Both sexes are included to reflect the patient population with upper tract urothelial carcinoma (UTUC) already being followed at the University of Michigan and allow exploration of potential differences in tolerability of awake ureteroscopy based on sex
- History of endoscopically managed UTUC at any time, or a suspected diagnosis of UTUC based on pre-procedure imaging, and is already planned for office-based ureteroscopic assessment
- Ability and willingness to complete and adhere to survey questions and responses throughout study duration
Who cannot join
- Known ureteral strictures
- Active urinary tract infection
- Need for general anesthesia due to patient or procedural factors
- History of inability to tolerate ureteroscopy under local anesthetic
- Anticipated need for laser ablation during the surveillance procedure
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
Michael Uy, MD, 734-936-7030, Uymichae@med.umich.edu
Khurshid Ghani, MD
About this study
Official title: A Prospective Clinical Assessment of Office-Based Ureteroscopy for Upper Tract Urothelial Carcinoma Utilizing a 6.3 French Single Use Digital Flexible Ureteroscope
This clinical trial tests how well office based ureteroscopy utilizing a single use digital, flexible ureteroscope works for the assessment of upper tract urothelial carcinoma. Ureteroscopy is a procedure in which a thin camera called a ureteroscope is used to assess patients with a known or suspected diagnosis of upper tract urothelial carcinoma. Ureteroscopy is traditionally performed in an operating room under general anesthesia. In this study, patients undergo ureteroscopy in the doctor's office using an ultra-thin ureteroscope, which is the narrowest instrument of its kind. Because of its small size, researchers believe this procedure can be completed in the office with minimal discomfort and high patient satisfaction, which may eliminate the risks of general anesthesia and reduce delays to diagnosis. Office based ureteroscopy utilizing a single use digital, flexible ureteroscope may be effective for the assessment of upper tract urothelial carcinoma.
- Being tested
- Analgesic Agent, Electronic Health Record Review, Lidocaine Topical, Medical Device Usage and Evaluation, Survey Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analgesic AgentDrug
Also called analgesic, Analgesic Drugs, Analgesics, Anodynes
Given PO
Electronic Health Record ReviewOther
Ancillary studies
Lidocaine TopicalDrug
Given intraurethrally
Medical Device Usage and EvaluationDevice
Undergo ureteroscopy using 6.3 Fr single use digital ureteroscope
Survey AdministrationOther
Ancillary studies
UreteroscopyProcedure or surgery
Undergo ureteroscopy
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (in office ureteroscopy) | Experimental | Patients receive lidocaine jelly intraurethrally for local anesthesia. Patients then undergo ureteroscopy using the 6.3 Fr single use digital ureteroscope. Per standard of care practice, patients receive pain medication PO on an as needed basis prior to and immediately after the procedure. Receives: Drug: Analgesic Agent; Other: Electronic Health Record Review; Drug: Lidocaine Topical; Device: Medical Device Usage and Evaluation; Other: Survey Administration; Procedure: Ureteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate
Defined as the ability to successfully perform and complete upper and lower tract surveillance with the 6.3 French ureteroscope in an office setting. A study-wide successful outcome will be defined as a success rate of 70%. The success rate will be reported as the count and proportion of participants with a successful outcome out of the number of enrolled participants. The corresponding 95% binomial Clopper-Pearson confidence interval will be reported.
Measured: On day of procedure
Secondary outcomes (3)
Pain
Assessed by intra- and peri-procedure patient reported outcomes with the visual analogue scale pain score, as well as the Patient-Reported Outcomes Measurement Information System Pain Interference and Intensity score. Will be summarized and displayed graphically with means, standard deviations and/or quartiles.
Measured: From baseline up to 7-10 days post procedure
Satisfaction
Assessed by the International Consultation on Incontinence-Satisfaction. Will be summarized and displayed graphically with means, standard deviations and/or quartiles.
Measured: At 7-10 days post procedure
Unplanned healthcare use
Will measure unplanned healthcare utilization including electronic messages, phone calls, lab and imaging tests, emergency department visits, hospitalizations, and secondary interventions. These will be reported as counts of events and counts of participants with corresponding proportions of enrolled participants.
Measured: From baseline up to 30 days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Pelvis and Ureter Urothelial CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen HugeMed Medical Technical Development
- Responsible party
- Sponsor
- Investigators
- Khurshid Ghani, MD, Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07630155
- Sponsor's protocol ID
- UMCC 2025.155
- Other IDs
- NCI-2026-03864, HUM00284243
- Status last verified
- Oct 2026
- First submitted
- 1 Jun 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Assessment of Office-Based Ureteroscopy for Upper Tract Urothelial Carcinoma Utilizing a 6.3 French Single Use Digital Flexible Ureteroscope
- ClinicalTrials.gov ID
- NCT07630155
- Acronym / sponsor ID
- UMCC 2025.155
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- Shenzhen HugeMed Medical Technical Development
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial tests how well office based ureteroscopy utilizing a single use digital, flexible ureteroscope works for the assessment of upper tract urothelial carcinoma. Ureteroscopy is a procedure in which a thin camera called a ureteroscope is used to assess patients with a known or suspected diagnosis of upper tract urothelial carcinoma. Ureteroscopy is traditionally performed in an operating room under general anesthesia. In this study, patients undergo ureteroscopy in the doctor's office using an ultra-thin ureteroscope, which is the narrowest instrument of its kind. Because of its small size, researchers believe this procedure can be completed in the office with minimal discomfort and high patient satisfaction, which may eliminate the risks of general anesthesia and reduce delays to diagnosis. Office based ureteroscopy utilizing a single use digital, flexible ureteroscope may be effective for the assessment of upper tract urothelial carcinoma.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (in office ureteroscopy) | Experimental | Drug: Analgesic Agent, Other: Electronic Health Record Review, Drug: Lidocaine Topical, Device: Medical Device Usage and Evaluation, Other: Survey Administration, Procedure: UreteroscopyPatients receive lidocaine jelly intraurethrally for local anesthesia. Patients then undergo ureteroscopy using the 6.3 Fr single use digital ureteroscope. Per standard of care practice, patients receive pain medication PO on an as needed basis prior to and immediately after the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged ≥ 18 year. Both sexes are included to reflect the patient population with upper tract urothelial carcinoma (UTUC) already being followed at the University of Michigan and allow exploration of potential differences in tolerability of awake ureteroscopy based on sex
- History of endoscopically managed UTUC at any time, or a suspected diagnosis of UTUC based on pre-procedure imaging, and is already planned for office-based ureteroscopic assessment
- Ability and willingness to complete and adhere to survey questions and responses throughout study duration
Key exclusion criteria (6 listed)
- Known ureteral strictures
- Active urinary tract infection
- Need for general anesthesia due to patient or procedural factors
- History of inability to tolerate ureteroscopy under local anesthetic
- Anticipated need for laser ablation during the surveillance procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Analgesic AgentAlso: analgesic, Analgesic Drugs, Analgesics, AnodynesGiven PO | Drug | Diagnostic (in office ureteroscopy) |
| Electronic Health Record ReviewAncillary studies | Other | Diagnostic (in office ureteroscopy) |
| Lidocaine TopicalGiven intraurethrally | Drug | Diagnostic (in office ureteroscopy) |
| Medical Device Usage and EvaluationUndergo ureteroscopy using 6.3 Fr single use digital ureteroscope | Device | Diagnostic (in office ureteroscopy) |
| Survey AdministrationAncillary studies | Other | Diagnostic (in office ureteroscopy) |
| UreteroscopyUndergo ureteroscopy | Procedure or surgery | Diagnostic (in office ureteroscopy) |
Primary outcome
Success rate
Time frame: On day of procedure
Defined as the ability to successfully perform and complete upper and lower tract surveillance with the 6.3 French ureteroscope in an office setting. A study-wide successful outcome will be defined as a success rate of 70%. The success rate will be reported as the count and proportion of participants with a successful outcome out of the number of enrolled participants. The corresponding 95% binomial Clopper-Pearson confidence interval will be reported.
3 secondary outcomes
Pain
Time frame: From baseline up to 7-10 days post procedure
Satisfaction
Time frame: At 7-10 days post procedure
Unplanned healthcare use
Time frame: From baseline up to 30 days post procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Khurshid Ghani, MD principal investigator
University of Michigan Rogel Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Analgesic Agent, Electronic Health Record Review and Lidocaine Topical in people with Renal Pelvis and Ureter Urothelial Carcinoma, run by University of Michigan Rogel Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Uy, MD (734-936-7030, Uymichae@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate (time frame: On day of procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.